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What are Nutraceuticals?

A nutraceutical is a food with a medical-health beneft, including the prevention and treatment of disease.
Te term was coined in the late 1980s by Stephen DeFelice, M.D., founder and chairman of the Foundation
for Innovation in Medicine.
Such foods also commonly are referred to as functional foods, signifying they and/or their components may
provide a health beneft beyond basic nutrition. Examples include fruits and vegetables as well as fortifed or
enhanced foods. While all foods are functional in that they provide nutrients, nutraceuticals contain health-
promoting ingredients or natural components that have a potential health beneft for the body. Functional
attributes of many traditional foods are being discovered, while new food products are being developed with
benefcial components.
Te concept of nutraceuticals is not entirely new, although it has evolved considerably over the years. In
the early 1900s, food manufacturers in the United States began adding iodine to salt in an efort to prevent
goiter (an enlargement of the thyroid gland), representing one of the frst attempts at creating a functional
component through fortifcation. Today, researchers have identifed hundreds of compounds with functional
qualities, and they continue to make new discoveries surrounding the complex benefts of phytochemicals
(non-nutritive plant chemicals that have protective or disease preventive properties) in foods.
Other Considerations:
Labeling and Health Claims
Regulations
Safety and Efcacy
Educational Activity:
Tinking Critically
Additional Resources:
A Glossary of Terms
Relevant Links
Overview of Nutraceuticals:
What are Nutraceuticals?
Traditional vs. Nontraditional
Applications of Nutraceuticals:
Current Applications
Research
NUTRACEUTICALS
aboutbioscience.org
OVERVIEW OF NUTRACEUTICALS
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Nutraceuticals are hugely popular among consumers in the U.S. and other parts of the world. American
sales for 2003 were an estimated $31 billion, and that fgure is expected to grow substantially over the
following several years. Nutraceuticals are one of the fastest-growing segments of the food industry,
especially among afuent baby boomers.
In Japan, England and other countries, nutraceuticals already have become part of the dietary landscape.
Consumer interest in the relationship between diet and health has increased the demand for information
on nutraceuticals. Rapid advances in science and technology, increasing health care costs, changes in food
laws afecting label and product claims, an aging population and rising interest in attaining wellness through
diet are among the factors fueling U.S. interest in nutraceuticals. Credible scientifc research indicates
many potential health benefts from food components. Tese benefts could expand the health claims now
permitted to be identifed by the Food and Drug Administration (FDA).
Traditional vs. Nontraditional
Nutraceuticals on the market today consist of
both traditional foods and nontraditional foods.
Traditional nutraceuticals are simply natural, whole
foods with new information about their potential
health qualities. Tere has been no change to the
actual foods, other than the way the consumer
perceives them. Many if not most fruits,
vegetables, grains, fsh, dairy and meat products
contain several natural components that deliver
benefts beyond basic nutrition, such as lycopene in tomatoes, omega-3 fatty acids in salmon or saponins in
soy. Even tea and chocolate have been noted in some studies to contain health-benefting attributes.
Nontraditional nutraceuticals, on the other hand, are foods resulting from agricultural breeding or added
nutrients and/or ingredients. Agricultural scientists are able to boost the nutritional content of certain
crops through the same breeding techniques that are used to bring out other benefcial traits in plants
and animals everything from beta-carotene-enriched rice to vitamin-enhanced broccoli and soybeans.
Research currently is being conducted to improve the nutritional quality of many other crops.
Foods specially formulated with nutrients or other ingredients include products such as orange juice fortifed
with calcium, cereals with added vitamins or minerals and four with added folic acid. In fact, more and more
foods are being fortifed with nutrients and other physiologically active components (such as plant stanols
and sterols) as researchers uncover more evidence about their role in health and disease-risk reduction.
Tomatoes and salmon are two types of food that researchers have
found to contain benefts beyond basic nutrition in this case,
lycopene and omega-3 fatty acids, respectively.
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APPLICATIONS OF NUTRACEUTICALS
Current Applications
Numerous nutraceuticals currently are on the market. Te following chart represents a sample of available
nutraceuticals, their components and their potential human health benefts.
Carotenoids
1. Beta-carotene Carrots, various fruits Neutralizes free radicals, which may damage
cells; bolsters cellular antioxidant defenses
2. Lycopene Tomatoes and processed tomato products May contribute to maintenance of prostate
health
Dietary Fiber
Insoluble fber Wheat bran May contribute to maintenance of a healthy
digestive tract
Fatty Acids
Monosaturated fatty acids Tree nuts May reduce risk of coronary heart disease
Flavonoids
Flavonols Onions, apples, tea, broccoli Neutralize free radicals, which may damage
cells; bolster cellular antioxidant defenses
Isothiocyanates
Sulforaphane Caulifower, broccoli, cabbage, kale,
horseradish
May enhance detoxifcation of undesirable
compounds and bolster cellular antioxidant
defenses
Phenols
Caffeic acid, ferulic acid Apples, pears, citrus fruits, some vegetables May bolster cellular antioxidant defenses;
may contribute to maintenance of vision and
heart health
Plant Stanols/Sterols
Stanol/sterol esters Fortifed table spreads, stanol ester dietary
supplements
May reduce risk of coronary heart disease
Polyols
Sugar alcohols (xylitol, sorbitol, mannitol,
lactitol)
Some chewing gums and other food
applications
May reduce risk of dental caries (cavities)
Prebiotics/Probiotics
Lactobacilli, bifdobacteria Yogurt, other dairy and nondairy applications May improve gastrointestinal health and
systematic immunity
Phytoestrogens
Isofavones (daidzein, genistein) Soybeans and soy-based foods May contribute to maintenance of bone health,
healthy brain and immune functions; for
women, maintenance of menopausal health
Soy Protein
Soy protein Soybeans and soy-based foods May reduce risk of coronary heart disease
Sulfdes/Thiols
Dithiolthiones Cruciferous vegetables May contribute to maintenance of healthy
immune function
CLASS/COMPONENTS SOURCE POTENTIAL BENEFIT
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Research
Functional foods currently on the market represent a small fraction of the possible products. Te vast
potential for functional foods will not be achieved without extensive scientifc research to ensure the
safety and efcacy of these products. Scientifc literature reports almost daily on new insights into the
role of existing nutrients, advances in identifying bioactive compounds and their health benefts and the
intersection of genomics and nutrition science in personalized nutrition. Continued basic and applied
nutritional research must pursue a more precise understanding of the mechanisms of action for known
nutrients.
Many scientists agree that studies using dietary intake databases such as the National Health and Nutrition
Examination Surveys (NHANES) can be useful in identifying relationships between diet and health.
Scientists want to see similar studies developed and databases such as the Department of Agriculture food-
component databases expanded and updated as better analytical methods become available.
In addition to government-supported research, food companies traditionally have funded research for
new food-product formulations. Incentives to the food industry would enhance greatly the development
of functional foods. Te research required for a functional food to meet scientifc standards for efcacy is a
substantial investment. Food companies do not have exclusive rights to a return on that investment, because
once the health claim is documented adequately, competing companies can use the claim for their own
similar products. Incentives such as a period of exclusivity or tax breaks would encourage food companies
to pursue functional food development as a proftable venture.
Additional research is needed in many areas to ensure this emerging science continues to be valid and is
translated rapidly into consumer-relevant products.
OTHER CONSIDERATIONS
Labeling and Health Claims
Health claims on nutraceuticals serve to alert consumers to a foods health potential by stating that
certain foods or food substances, as part of an overall healthy diet, may reduce the risk of certain diseases.
Examples include folic acid in breakfast cereals, fber in fruits and vegetables, calcium in dairy products and
calcium or folic acid in some dietary supplements. Food and food substances can qualify for health claims
only if they meet FDA requirements. Te FDA initially authorized seven health claims in 1993 as part of the
1990 Nutrition Labeling and Education Act (NLEA). Since 1993, the FDA has authorized six more claims.
Under the NLEA, companies petition the FDA to consider new health claims through rule-making.
However, this process may require more than a year to complete because of the necessary scientifc
review and the need to issue a proposed rule to allow for public comment. In an efort to accelerate this
information to consumers, the Food and Drug Administration Modernization Act of 1997 included a
provision intended to expedite the process that establishes the scientifc basis for health claims.
Although food manufacturers may use health claims to market their products, the intended purpose of
health claims is to beneft consumers by providing information on healthful eating patterns that may help
reduce the risk of heart disease, cancer, osteoporosis, high blood pressure, dental cavities or certain birth
defects.
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Te following are the FDA-approved health claims showing a positive relationship between a certain
compound and reduced risk of specifc disease(s):
Potassium High blood pressure and stroke
Plant sterol and plant stanol esters Coronary heart disease
Soy protein Coronary heart disease
Calcium Osteoporosis
Fiber-containing grain products, fruits and vegetables Cancer
Fruits, vegetables and grain products that contain fber,
particularly soluble fber Coronary heart disease
Fruits and vegetables Cancer
Folic acid Neural tube birth defects
Dietary soluble fber, such as that found in whole oats
and psyllium seed husk Coronary heart disease
Dietary sugar alcohol Dental caries (cavities)
Te remaining three FDA-approved health claims are based on diets low in negative nutrients in food,
such as sodium. Tese health claims shows a relationship between certain compounds and an increased risk
of disease(s):
Dietary fat Cancer
Dietary saturated fat and cholesterol Coronary heart disease
Sodium High blood pressure
Health claims are among the various types of claims allowed in food labeling. Tey show a relationship
between a nutrient (or other substances in a food) and a disease or health-related condition. Tey difer
from the more common claims that highlight a foods nutritional content, such as low fat, high fber and
low calorie.
Health claims also are diferent from structure/function claims,
which also may appear on conventional food or dietary supplement
labels. Manufacturers may make statements about a food substances
efect on the structure or function of the body for example,
calcium builds strong bones. Unlike health claims, structure/
function claims do not deal with disease-risk reduction. Also, the
FDA does not preapprove or authorize structure/function claims.
Rather, when the manufacturer uses a structure/function claim, the
company is responsible for making sure the claim is truthful and not
misleading.
Many academic, scientifc and regulatory organizations are
considering ways to establish the scientifc basis to support claims
(other than health claims) for the functional components of
nutraceuticals. Tese are the fve types of health-related statements
allowed on food and dietary supplement labels:
Nutrient-content claims indicate the presence of a specifc nutrient at a certain level.
Structure and function claims describe the efect of dietary components on the normal structure or
function of the body.
Dietary-guidance claims describe the health benefts of broad categories of foods.
Qualifed health claims convey a developing relationship between components in the diet and risk of
disease, as approved by the FDA and supported by the weight of credible scientifc evidence available.

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COURTESY FDA
The Food and Drug Administration is the federal
agency that authorizes health claims for foods
and food substances.
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Health claims confrm a relationship between components in the diet and risk of disease or health
condition, as approved by FDA and supported by signifcant scientifc agreement.
A large body of credible scientifc research is needed to confrm the benefts of any particular food or
component. For nutraceuticals to deliver their potential health benefts, consumers must have a clear
understanding of and a strong confdence level in the scientifc criteria that are used to document health
efects and claims.
Regulations
Nutraceuticals have no ofcial meaning and do not constitute a distinct category of foods. Most ofen, they
are simply natural, whole foods consumers have been eating for thousands of years. As a result, the FDA
regulates them in the same way they regulate all foods: Te safety of ingredients must be assured in advance,
and all claims must be substantiated, truthful and nonmisleading.
Safety and Effcacy
Nutraceuticals hold great potential, as evidenced by products such as
Benecol, an alternative to margarine that contains plant stanol esters,
which have been shown to reduce cholesterol. Yet, they also may
hold the potential for harm, as was the case with ephedrine, a widely
used botanical ingredient in weight-loss products. Te substance was
banned by the FDA afer it was linked to signifcant adverse health
efects, including heart attack and stroke.
Even afer highly publicized events like the ephedrine ban, vast
numbers of consumers continue to buy nutraceuticals. Consumers
desire the increased health control these products ofer and the
promised health benefts. Te danger is that many of these products do
not provide consumers with solid information about their safety and
efectiveness, possible side efects, interactions with prescription medicines or the impact they may have on
existing medical conditions.
While acceptance of nutraceuticals is growing among physicians, many members of the medical and
scientifc communities remain concerned that many products entering the market lack adequate efcacy
and safety data. Professionals on both sides of the fence agree there is an urgent need for funding to support
high-quality scientifc research, testing and clinical trials before nutraceuticals are introduced to consumers.
Clinical research on specifc nutraceutical products sold would help substantiate the potential medical or
health values of these products. As a result, patients and health care professionals would know the facts
about the beneft and the safety of the products being taken.
5.
COURTESY CENTER FOR SCIENCE IN THE PUBLIC INTEREST
A tub of Benecol featuring a logo that touts its
cholesterol-reducing ability.
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EDUCATIONAL ACTIVITY
Thinking Critically
Te following educational activity is intended for high school students studying nutraceuticals.
Following a lesson plan on nutraceuticals, divide students into groups and ask them to answer and discuss
the following questions:
What is a functional food or nutraceutical?
Why are fruit and vegetables good for us?
Our increased awareness of the link between diet and health hasnt gone unnoticed by food
manufacturers. What changes have they made?
What do spinach, Brussels sprouts, avocados and oranges have in common? How are they diferent?
What are the possible health consequences if pregnant women do not get enough folate in their diet?
What does RDI stand for?
Next, supply students with various newspaper clippings and ask students to look for foods and products
that promote healthy living. Be sure to include pages from the foods section of the paper. Students then
should make a list of the words and phrases that are used to persuade consumers these products are healthy.
Students can share their fndings with the class. Tis activity will help students understand the role of
advertising on food selection. Foods now and in the future will be designed to increase life spans, promote
health and fght disease.
Encourage students to continue researching the relationship between the food they eat and their health by
keeping a daily food diary. Students should note all the foods they consume, including meals and snacks,
during a one-week time period. Afer one week, students can bring their food journals into class and share
their fndings with class members.
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A Glossary of Terms
Amino acid: One of the building blocks of protein.
Antioxidant: A substance that blocks or inhibits the actions of free radicals, molecules that speed up the
aging process and contribute to illness. Free radicals are found in rancid fats and oils and environmental
hazards.
Arteriosclerosis: Condition in which the walls of arteries become hard and thick, sometimes interfering
with blood circulation.
Botanical: A plant-based product.
Cafeic acid: An acid obtained from cofee tannin, as a yellow crystalline substance.
Carotenoids: One of the most widespread groups of naturally occurring pigments. Tese compounds
largely are responsible for the red, yellow and orange color of fruits and vegetables and also are found in
many dark green vegetables.
Chelation: A process that wraps or binds the minerals in amino acids, it uses an agent, such as the chemical
compound EDTA, to remove heavy metals from the body.
Complementary and alternative medicine (CAM): A group of diverse medical and health care systems,
practices and products that presently are not considered part of conventional medicine. Complementary
medicine is used together with conventional medicine. Alternative medicine is used in place of conventional
medicine.
Dietary supplement: Congress defned the term in the Dietary Supplement Health and Education Act
of 1994 as a product taken by mouth that contains a dietary ingredient intended to supplement the diet.
Te dietary ingredients may include vitamins, minerals, herbs or other botanicals, amino acids or dietary
substances to supplement the diet by increasing the total dietary intake. Dietary supplements can be
concentrates, metabolites, constituents or extracts. Tey may be found in tablets, capsules, sofgels, gelcaps,
liquids or powders. Tey also can be in other forms, such as a bar; in this case, information on the label
must not represent the product as a conventional food or a sole item of a meal or diet.
Dietary Supplement Health and Education Act (DSHEA): Passed in 1994, this law amended the Federal
Food, Drug, and Cosmetic Act. It created a new regulatory framework for the safety and labeling of dietary
supplements, placing them in a special category under the general umbrella of foods and requiring them to
be labeled as dietary supplements.
Enzyme: A complex protein produced by cells that acts as a catalyst in specifc biochemical reactions.
Ferulic acid: A compound, C
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H
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O
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, related to vanillin and obtained from certain plants.
Flavonoids: A class of water-soluble plant pigments.
Genetically engineered food: A food substance that has foreign genes inserted into its genetic code.
Genetic engineering can be done with plants, animals or microorganisms. Scientists can move desired genes
from one plant into another and even from an animal to a plant, or vice versa.
ADDITIONAL RESOURCES
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Herb: A plant lacking a permanent woody stem.
Holistic medicine: An approach to medical care that emphasizes the study of all aspects of a persons health,
including physical, psychological, social, economic and cultural factors.
Homeopathy: A complementary and alternative medical system. In homeopathic medicine, there is a belief
that small, highly diluted quantities of medicinal substances are given to cure symptoms, when the same
substances given at higher or more concentrated doses actually would cause those symptoms.
Isofavones: A class of organic compounds and biomolecules related to the favonoids. Tey act as
phytoestrogens, which are thought by many to be useful in treating cancer.
Isothiocyanates: Sulfur-containing compounds that largely are responsible for the typical favor of
cruciferous vegetables.
Labeling: Te product label and accompanying material that is used by a manufacturer to promote and
market a specifc product.
Mineral: A naturally occurring inorganic substance with a defnite and predictable chemical composition
and physical properties.
New dietary ingredient: A dietary ingredient not sold in the United States in a dietary supplement before
Oct. 15, 1994.
Nutraceutical: Te term coined in the 1990s by Dr. Stephen DeFelice, who defned it as any substance that
is a food or a part of a food and provides medical or health benefts, including the prevention and treatment
of disease. Such products may range from isolated nutrients, dietary supplements and specifc diets to
genetically engineered designer foods, herbal products and processed foods such as cereals, soups and
beverages. Since the term was coined, its meaning has been modifed. Te term also has been defned as a
product isolated or purifed from foods and generally sold in medicinal forms not usually associated with
food and demonstrated to have a physiological beneft or provide protection against chronic disease.
Nutrient: Any substance that can be metabolized by an organism to give energy and build tissue.
Phenols: Also known under the older name of carbolic acid, a colorless crystalline solid with a typical sweet
tarry odor.
Phytoestrogens: Compounds that occur naturally in plants (phyto) and under certain circumstances can
have actions like human estrogen.
Plant stanols and sterols: Essential components of plant cell membranes that resemble cholesterol
structurally. Plant sterols are present naturally in small quantities in many fruits, vegetables, nuts, seeds,
cereals, legumes, vegetable oils and other plant sources. Plant stanols occur in even smaller quantities than
plant sterols in many of the same sources.
Polyols: Chemical compounds containing multiple hydroxyl groups. Sugar alcohols, a class of polyols,
commonly are added to foods because of their lower caloric content.
Potentiated: 1. To enhance or increase the efect of a drug. 2. To promote or strengthen a biochemical or
physiological action or efect.
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Prebiotics: Food substances that promote the growth of certain bacteria (generally benefcial) in the
intestines.
Probiotics: Dietary supplements containing potentially benefcial bacteria or yeast.
Saponins: Any of various plant glucosides that form soapy lathers when mixed and agitated with water.
Tey are used in detergents, foaming agents and emulsifers.
Sulfdes: Refers to several types of chemical compounds containing sulfur.
Tiols: Compounds containing the functional group composed of a sulfur atom and a hydrogen atom.
Vitamin: An organic substance essential in small quantities to normal metabolism.
Relevant Links
http://www.fda.gov
Te Food and Drug Administration is responsible for protecting the public health by assuring the safety,
efcacy and security of human and veterinary drugs, biological products, medical devices, our nations food
supply, cosmetics and products that emit radiation. Tis site contains information related to the regulation
of foods, including nutraceuticals, as well as information on health claims.
http://www.fmdefelice.org
Te Foundation for Innovation in Medicine was established in 1976 by Stephen L. DeFelice, M.D. It is
a nonproft foundation whose purpose is to accelerate medical discovery by creating a more productive
clinical research community. Use the tool bar on the lef side of the Web site and click on Library to navigate
through various articles, fact sheets and press releases related to nutraceuticals. Make sure to check out the
links page as well.
http://ifc.org/index.cfm
Te IFIC Foundation is the educational arm of the International Food Information Council. Te IFICs
purpose is to bridge the gap between science and communications. It collects and disseminates scientifc
information on food safety, nutrition and health, works with scientifc experts and establishes partnerships
to help translate research into understandable and useful information for opinion leaders and, ultimately,
consumers. Search for functional foods to fnd fact sheets related to the general topic as well as
information on specifc foods and their reported health benefts.
http://www.if.org/cms
Founded in 1939, the Institute of Food Technologists is a nonproft scientifc society with 22,000 members
working in food science, food technology and related professions in industry, academia and government.
Te site contains a 66-page, in-depth and authoritative report, Functional Foods: Opportunities and
Challenges, which covers all topics related to nutraceuticals.

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